BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS OCT SPINAL FIXATION SYSTEM

    MDR report key: 16402168 · Received February 20, 2023

    Report

    Report Number
    2027467-2023-00007
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 18, 2023
    Manufacturer
    ALPHATEC SPINE, INC
    Product Code
    NKG
    UDI-DI
    00190376303697
    PMA / PMN Number
    K203125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B2. 80, (B)(6) 1942. B3. MALE. H6. INVESTIGATION FINDINGS: 3243. INVESTIGATION CONCLUSION: 61. H10: DEVICE EVALUATION: A REVIEW OF THE DHR INDICATED NO REMARKABLE MANUFACTURING OR QUALITY ITEMS THAT WOULD HAVE IMPACTED PERFORMANCE RELATIVE TO THE COMPLAINT BEYOND THE INTENDED DESIGN. THERE ARE NO CLEAR INDICATIONS THAT THE DESIGN, MANUFACTURING, OR INITIAL QUALITY OF THE IMPLANT CONTRIBUTED TO THE COMPLAINT. QTY (B)(4) OF PN 19000-55-30 LN TO00550 WERE MANUFACTURED TO DRAWING REV B AND RELEASED INTO INVENTORY ON 01/18/2022. THE INVICTUS OCT POLYAXIAL SCREW PN 19000-55-30 WAS VISUALLY AND PHYSICALLY EXAMINED UPON RECEIPT AND SHOWED NO APPARENT SIGNS OF MANUFACTURING DEFECT. THE SCREW WAS RECEIVED NOT INTACT AND RETURNED WITH A SHANK FACTURE AT THE NECK OF THE SCREW. ADDITIONAL DAMAGE AND MARKINGS TO THE SCREW WERE OBSERVED AND ARE ATTRIBUTED TO THE REMOVAL AND RETRIEVAL OF THE IMPLANT DURING THE SURGERY. THE RETURNED IMPLANT SHANK CLEARLY INDICATES A FRACTURE AT THE NECK MOST LIKELY DUE TO EXCESS TORSIONAL LOAD. THE FOLLOWING TESTING AND CHARACTERIZATION DATA FOR THIS DESIGN IS SUMMARIZED BELOW FOR AN EVALUATED 4.5MM SCREW IN COMPARISON TO THE RETURNED 5.5MM SCREW WHICH SHARE THE SAME NECK DIAMETER OF .109" (2.77MM). 4.5MM SCREWS WERE TORQUED TO FAILURE IN A VISE AS WELL AS INSERTED INTO 40 AND 50 PCF BONE FOAM IN ORDER TO COMPARE TO THE COMPLAINT FAILURES. RESULTS AND IMAGES ARE CAPTURED IN THE TABLES BELOW. THE 19000-45-40 FAILURES EXHIBITED SIMILAR WITNESS MARKS AS THOSE SEEN IN THE INVESTIGATION IMPLANT FOR BOTH STRICT TORSIONAL FAILURES & LATERAL BENDING FAILURES. THE ROOT CAUSE IS DUE TO THE TORSIONAL LOAD EXPERIENCED EXCEEDED THE DESIGN LIMITATIONS FOR THE SHANK AND DESIGN TESTED AND APPROVED.

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE. DURING SCREW INSERTION, THE RATCHETING HANDLES WERE TORQUING OUT AND WOULD NOT FULLY DRIVE THE SCREW IN. THE POLYAXIAL SCREW BROKE JUST BELOW THE TULIP. ALL THE PIECES WERE RETRIEVED, AND A NEW SCREW WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320209 INVICTUS OCT SPINAL FIXATION SYSTEM POSTERIOR CERVICAL SCREW SYSTEM NKG ALPHATEC SPINE, INC 19000-55-30 TO00550 00190376303697

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown